NDC codes

FDA NDC Directory
Product NDC (as listed)60505-0813Labeler and product segments. Claims need a package NDC.
Product NDC at billing width60505-0813Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
60505-0813-1605050813011 BOTTLE, SPRAY in 1 CONTAINER (60505-0813-1) / 2.5 mL in 1 BOTTLE, SPRAYMarketed from Dec 4, 2002

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary)
Butorphanol Tartrate
Generic name (nonproprietary)
butorphanol tartrate
Active ingredients
Butorphanol tartrate — 10 mg/mL
Dosage form
Spray
Route
Nasal
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 075499
Marketing start
Listing expires
DEA schedule
CIV
Other FDA classes
Competitive Opioid Antagonists (Mechanism)Partial Opioid Agonists (Mechanism)
Identifiers
Product ID 60505-0813_ff8775a3-e234-577e-5492-beb7a49e3f22SPL ID ff8775a3-e234-577e-5492-beb7a49e3f22SPL set ID b8e48063-0b40-ee43-85c1-4ef2de80c404RxCUI 886634UNII 2L7I72RUHN
Pharmacologic class
Opioid Agonist/Antagonist

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Nasal products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N460505081301 followed by a unit qualifier and the quantity

Package 60505-0813-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective . This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Butorphanol tartrate nasal spray is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use : Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration, and persist over the course of therapy [see WARNINGS ] , reserve opioid analgesics, including butorphanol tartrate, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 075499

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 075499
ProductStrengthForm · routeLabelerProduct NDC
Butorphanol TartrateButorphanol tartrate 10 mg/mLSprayNasalBryant Ranch Prepack72162-2099

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free Med-Code account to keep looking up NDCs, J-codes and drugs.

Create a free accountLog in